MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that an unknown patient underwent an av node ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was separation of the material of the shaft of the catheter and the proximal visualization electrode of the catheter.It was reported that the deflection was not adequate.The physician said the catheter was not deflecting as it was expected to, no deflection when out of the patient.The catheter was removed un-deflected.It was also noted that there was separation of the material of the shaft of the catheter and the proximal visualization electrode of the catheter.The catheter was replaced, and the issue was resolved.The procedure was continued.Deflation issue is not mdr-reportable.Detached shaft is mdr-reportable.

Manufacturer Narrative

On 4-jan-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 15-jan-2021, bwi received additional information regarding the event.It appears that braid may be exposed.It does not appear that rings are lifted or sharp.There was no resistance or difficulty with insertion or removal of device.There was no detachment of device.The catheter was being used and inside patient when physician noticed deflections weren¿t working appropriately.Furthermore, the product investigation was subsequently completed.Device evaluation details: a picture showing the catheter tip was received for analysis, the photo does not provide sufficient information since the piston is not shown in the image and therefore no result can be obtained from it.In addition, no damage was observed.The complaint device had also been returned for analysis.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smarttouch sf (bidirectional).No evidence of material separation was found.A deflection test was performed in accordance with bwi procedures.The device was deflecting correctly, and no anomalies were observed during the test.A manufacturing record evaluation was performed for the finished device 30643008l number, and no non-conformances related to the reported complaint condition were identified.,mre review: a manufacturing record evaluation was performed for the finished device 30643008l number, and no internal actions related to the reported complaint condition were identified.The event described could not be confirmed as the device performed without any deflection issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13086766
• MDR Text Key: 282783886
• Report Number: 2029046-2021-02250
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30643008L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1